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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE Back to Search Results
Model Number V60 V60PLUS VENTILATOR
Device Problem Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/14/2024
Event Type  malfunction  
Event Description
Philips received a complaint by the customer on the v60, indicating that there was a patient disconnect issue.It was reported that there was no patient involvement at the time the issue was discovered.The customer called technical support to report that there was a patient disconnect issue.Resolution and disposition are pending.
 
Manufacturer Narrative
E1: reporting institution name: (b)(6).Reporting address state: (b)(6).Reporting address postal: (b)(6).Reporting institution phone #: (b)(6).Reporter phone #: (b)(6).G1 contact office phone: (b)(6).
 
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Brand Name
RESPIRONICS
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer (Section G)
RESPIRONICS, INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer Contact
melissa rosko
1001 murry ridge lane
murrysville, PA 15668
7247330200
MDR Report Key19193379
MDR Text Key341165437
Report Number2518422-2024-22827
Device Sequence Number1
Product Code MNT
UDI-Device Identifier00884838025776
UDI-Public00884838025776
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K102985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberV60 V60PLUS VENTILATOR
Device Catalogue Number1076716
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/14/2024
Date Device Manufactured02/18/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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